Publications

SmartPill(R) as an objective parameter for determination of severity and duration of postoperative ileus: study protocol of a prospective, two-arm, open-label trial (the PIDuSA study).

Abstract (Expand)

INTRODUCTION: Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence … of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill((R)), a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill((R)) immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking. METHODS AND ANALYSIS: The PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill((R)) will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill((R)) in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill((R)) to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill((R)) will be analysed. ETHICS AND DISSEMINATION: The protocol was approved by the federal authority (94.1.05-5660-8976) and the local ethics committee (092/14-MPG). Findings will be disseminated through publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02329912; Pre-results.

Authors: T. O. Vilz, D. Pantelis, P. Lingohr, R. Fimmers, A. Esmann, T. Randau, J. C. Kalff, M. Coenen, S. Wehner

Date Published: 8th Jul 2016

Publication Type: Journal

Structure and function of corpus luteum during gestation in the viviparous lizard Chalcides ocellatus.

Abstract

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Author: N. Badir

Date Published: 1968

Publication Type: Journal

Real-time use of artificial intelligence (CADEYE) in colorectal cancer surveillance of patients with Lynch syndrome—A randomized controlled pilot trial (CADLY)

Abstract

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Editor:

Date Published: 26th Dec 2022

Publication Type: Unpublished

Efficacy and safety of guselkumab in European patients with palmoplantar pustulosis: A multi-center, single-arm clinical trial (GAP study)

Abstract

Not specified

Authors: Dagmar Wilsmann-Theis, Selina Patt, Andreas Pinter, Sascha Gerdes, Nina Magnolo, Robert Németh, Jennifer Schmitz, Cornelia Paul, Matthias Augustin, Petra Staubach, Ansgar Weyergraf, Ulrike Hüffmeier, Kerstin Wolk, Robert Sabat, Rotraut Mößner

Date Published: 1st Feb 2025

Publication Type: Journal

SmartPill ® as an objective parameter for determination of severity and duration of postoperative ileus: study protocol of a prospective, two-arm, open-label trial (the PIDuSA study)

Abstract (Expand)

Introduction Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence …ce-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill ® , a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill ® immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking. Methods and analysis The PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill ® will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill ® in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill ® to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill ® will be analysed. Ethics and dissemination The protocol was approved by the federal authority (94.1.05-5660-8976) and the local ethics committee (092/14-MPG). Findings will be disseminated through publications and conference presentations. Trial registration number NCT02329912; Pre-results.

Authors: Tim O Vilz, Dimitrios Pantelis, Philipp Lingohr, Rolf Fimmers, Anke Esmann, Thomas Randau, Jörg C Kalff, Martin Coenen, Sven Wehner

Date Published: 8th Jul 2016

Publication Type: Journal

Safety and Suitability of the SmartPill® after Abdominal Surgery: Results of the Prospective, Two-Armed, Open-Label PIDuSA Trial

Abstract

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Editor:

Date Published: No date defined

Publication Type: Journal

Real‐time use of artificial intelligence (CADEYE) in colorectal cancer surveillance of patients with Lynch syndrome—A randomized controlled pilot trial (CADLY)

Abstract (Expand)

Abstract Background Lynch syndrome (LS), an autosomal dominant disorder caused by pathogenic germline variants in DNA mismatch repair (MMR) genes, represents the most common hereditary colorectal cancer …represents the most common hereditary colorectal cancer (CRC) syndrome. Lynch syndrome patients are at high risk of CRC despite regular endoscopic surveillance. Objective Our aim was to investigate the diagnostic performance of artificial intelligence (AI)‐assisted colonoscopy in comparison to High‐Definition white‐light endoscopy (HD‐WLE) for the first time. Methods Patients ≥18 years with LS, with a pathogenic germline variant ( MLH1 , MHS2 , MSH6 ), and at least one previous colonoscopy (interval 10–36 months) were eligible. Patients were stratified by previous CRC and affected MMR gene with a 1:1 allocation ratio (AI‐assisted vs. HD white‐light endoscopy) in this exploratory pilot trial. Results Between Dec‐2021 and Dec‐2022, 101 LS patients were randomised and 96 patients were finally analyzed after exclusion of 5 patients due to insufficient bowel preparation. In the HD‐WLE arm, adenomas were detected in 12/46 patients compared to 18/50 in the AI arm (26.1% [95% CI 14.3–41.1] vs. 36.0% [22.9–50.8]; p  = 0.379). The use of AI‐assisted colonoscopy especially increased detection of flat adenomas (Paris classification 0‐IIb) (examinations with detected flat adenomas: 3/46 [6.5%] vs. 10/50 [20%]; p  = 0.07; numbers of detected flat adenomas: 4/20 vs. 17/30, p  = 0.018). The median withdrawal time did not differ significantly between HD‐WLE and AI (14 vs. 15 min; p  = 0.170). Conclusion We here present first data suggesting that real‐time AI‐assisted colonoscopy is a promising approach to optimize endoscopic surveillance in LS patients, in particular to improve the detection of flat adenomas.

Authors: Robert Hüneburg, Karolin Bucksch, Friederike Schmeißer, Dominik Heling, Tim Marwitz, Stefan Aretz, Dominik J. Kaczmarek, Glen Kristiansen, Oliver Hommerding, Christian P. Strassburg, Christoph Engel, Jacob Nattermann

Date Published: 1st Feb 2023

Publication Type: Journal

Chromoendoskopie versus konventionelle Endoskopie im oberen Gastrointestinaltrakt bei Patienten mit familiärer adenomatöser Polyposis (ChroPol-I)

Abstract

Not specified

Authors: R Hüneburg, D Heling, DJ Kaczmarek, P van Heteren, R Fimmers, C Coch, G Kristiansen, T Weismüller, I Spier, S Aretz, CP Strassburg, J Nattermann

Date Published: 13th Aug 2018

Publication Type: Journal

RANIBIZUMAB IN PIGMENT EPITHELIAL TEARS SECONDARY TO AGE-RELATED MACULAR DEGENERATION

Abstract (Expand)

Purpose: To assess efficacy of intravitreal ranibizumab in retinal pigment epithelium tears secondary to neovascular age-related macular degeneration. Methods: The Ranibizumab In Pigment epithelial … Methods: The Ranibizumab In Pigment epithelial tears secondary to age-related macular degeneration (RIP) study is a prospective, single-arm, multicenter, investigator-initiated trial. Twenty four eyes of 24 patients with a retinal pigment epithelium tear secondary to age-related macular degeneration received monthly intravitreal injection of 0.5mg ranibizumab for 12 months, together with monthly assessments of morphologic and functional efficacy parameters. Primary outcome measure was mean best-corrected visual acuity at final visit compared with baseline. Results: Mean best-corrected visual acuity remained stable over the 12-month study period with 50.3 Early Treatment of Diabetic Retinopathy Study letters (±18.7; Snellen equivalent 20/100) at baseline and 52.9 letters (±19.7; Snellen equivalent 20/100) at final visit ( P = 0.39). One eye (4%) experienced a vision loss of ≥15 letters, and 2 eyes (8%) gained ≥15 letters. Mean central retinal thickness decreased from 571 µ m (±185 µ m) to 436 µ m (±171 µ m; P = 0.0001). Vision-related quality of life was stable with a mean VFQ-25 score of 79.0 (±10.8) at baseline and 74.3 (±13.9) at final visit ( P = 0.12). Conclusion: In retinal pigment epithelium tears secondary to age-related macular degeneration, monthly intravitreal ranibizumab therapy results in stabilization of visual acuity over 12 months.

Authors: Petra P. Larsen, Akio Oishi, Mohammad Seleman Bedar, Philipp K. R. Heymer, Christoph R. Clemens, Susanna König, Matthias Gutfleisch, Daniel Pauleikhoff, Nicole Eter, Armin Wolf, Frank G. Holz, Tim U. Krohne

Date Published: 2019

Publication Type: Journal

Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA–09): a randomised, open-label, phase 3 trial

Abstract

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Authors: Ulrich Herrlinger, Theophilos Tzaridis, Frederic Mack, Joachim Peter Steinbach, Uwe Schlegel, Michael Sabel, Peter Hau, Rolf-Dieter Kortmann, Dietmar Krex, Oliver Grauer, Roland Goldbrunner, Oliver Schnell, Oliver Bähr, Martin Uhl, Clemens Seidel, Ghazaleh Tabatabai, Thomas Kowalski, Florian Ringel, Friederike Schmidt-Graf, Bogdana Suchorska, Stefanie Brehmer, Astrid Weyerbrock, Miriam Renovanz, Lars Bullinger, Norbert Galldiks, Peter Vajkoczy, Martin Misch, Hartmut Vatter, Moritz Stuplich, Niklas Schäfer, Sied Kebir, Johannes Weller, Christina Schaub, Walter Stummer, Jörg-Christian Tonn, Matthias Simon, Vera C Keil, Michael Nelles, Horst Urbach, Martin Coenen, Wolfgang Wick, Michael Weller, Rolf Fimmers, Matthias Schmid, Elke Hattingen, Torsten Pietsch, Christoph Coch, Martin Glas

Date Published: 1st Feb 2019

Publication Type: Journal

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